FDA Adverse Event Injury Summary report: N

UNKNOWN

MDR report key: 7187056 · Received January 12, 2018

Report

Report Number: 1820334-2018-00116
Event Type: Injury
Date Received: January 12, 2018
Report Date: January 31, 2018
Manufacturer: COOK INC
Product Code: DTK
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: TX, US
Reporter Occupation: ATTORNEY

Narratives

Additional Manufacturer Narrative · 0

BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE OR UNCHANGED. IT HAS NOT BEEN POSSIBLE TO FURTHER INVESTIGATE OR EVALUATE THIS ALLEGED EVENT BASED ON THE LIMITED INFORMATION PROVIDED TO DATE VIA THE OPERATIVE NOTE STATING ¿GUNTHER TULIP FILTER IMPLANTED". COOK WILL REOPEN ITS INVESTIGATION IF FURTHER INFORMATION IS RECEIVED WARRANTING SUPPLEMENTATION IN ACCORDANCE WITH 21 C.F.R. 803.56. RPN AND LOT# ARE UNKNOWN, BUT THE FILTER TULIP IS MANUFACTURED AND INSPECTED ACCORDING TO (B)(4) (TULIP MI) AND (B)(4) (TULIP QCI). NO EVIDENCE TO SUGGEST THAT THIS DEVICE WAS NOT MANUFACTURED ACCORDING TO SPECIFICATIONS AND NOTHING INDICATES THAT THE FILTER DID NOT PERFORM AS INTENDED, E.G. INTENDED FOR THE PREVENTION OF RECURRENT PULMONARY EMBOLISM (PE) VIA PLACEMENT IN THE VENA CAVA.

Additional Manufacturer Narrative · 1

THE EVENT IS CURRENTLY UNDER INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION.

Description of Event or Problem · 1

IT IS ALLEGED THAT THE PLAINTIFF RECEIVED A GUNTHER FILTER ON (B)(6) 2007. IT IS ALLEGED THAT THE PLAINTIFF WAS INJURED WITHOUT FURTHER EXPLANATION. HOSPITAL AND MEDICAL RECORDS HAVE BEEN REQUESTED BUT NOT YET PROVIDED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
32080	UNKNOWN	DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR	DTK	COOK INC

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other